Safety and Efficacy of Talampanel in Glioblastoma Multiforme

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Talampanel

Radiation Therapy (RT) 5 days a week +

temozolomide(TMZ) 75mg

adjuvant TMZ 200mg

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients must be 18 years of age Patients must have histologically confirmed supratentorial Grade IV astrocytoma (glioblastoma multiforme) Patients must not have prior radiation therapy, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed. Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (on increase for 5 days) prior to the start of treatment. Patients must have a Karnofsky performance of at least 60% or more. Exclusion Criteria: Patients with serious concurrent infection or medical illness. Patients receiving concurrent chemotherapeutics or investigational agents.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

enzyme-inducing antiseizure drug

Arm Description

A single-arm study with all subjects assigned to one treatment (radiation + temozolomide + talampanel) but subjects receiving concomitant anti-seizure drugs which could increase study drug elimination had a slightly modified dose/schedule of study drug. The primary endpoint is analyzed as a single group.

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Talampanel-related toxicity

Full Information

NCT ID

NCT00267592

First Posted

December 19, 2005

Last Updated

April 20, 2016

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00267592

Brief Title

Safety and Efficacy of Talampanel in Glioblastoma Multiforme

Official Title

A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to estimate overall survival for adult patients with newly diagnosed glioblastoma multiforme treated with talampanel during radiation therapy with concurrent and adjuvant temozolomide. This study will also determine the toxicity and toxicity rate of talampanel for this therapeutic regimen.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma Multiforme

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

enzyme-inducing antiseizure drug

Arm Type

Experimental

Arm Description

A single-arm study with all subjects assigned to one treatment (radiation + temozolomide + talampanel) but subjects receiving concomitant anti-seizure drugs which could increase study drug elimination had a slightly modified dose/schedule of study drug. The primary endpoint is analyzed as a single group.

Intervention Type

Drug

Intervention Name(s)

Talampanel

Intervention Description

Talampanel administered orally TID beginning the first day and continued until there is talampanel-related toxicity or tumor progression.

Intervention Type

Radiation

Intervention Name(s)

Radiation Therapy (RT) 5 days a week +

Intervention Type

Drug

Intervention Name(s)

temozolomide(TMZ) 75mg

Intervention Description

temozolomide(TMZ) 75mg 3 times daily (TID) for 6 weeks

Intervention Type

Drug

Intervention Name(s)

adjuvant TMZ 200mg

Intervention Description

adjuvant TMZ 200mg TID for 5 consecutive days each month for a total of 6 months.

Primary Outcome Measure Information:

Title

Overall Survival

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Talampanel-related toxicity

Time Frame

29 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Patients must be 18 years of age Patients must have histologically confirmed supratentorial Grade IV astrocytoma (glioblastoma multiforme) Patients must not have prior radiation therapy, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed. Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (on increase for 5 days) prior to the start of treatment. Patients must have a Karnofsky performance of at least 60% or more. Exclusion Criteria: Patients with serious concurrent infection or medical illness. Patients receiving concurrent chemotherapeutics or investigational agents.

Glioblastoma Multiforme

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial